The following data is part of a premarket notification filed by Cardionet with the FDA for Cardionet Ambulatory Ecg Monitor, Model Cn1000a.
| Device ID | K003707 |
| 510k Number | K003707 |
| Device Name: | CARDIONET AMBULATORY ECG MONITOR, MODEL CN1000A |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | CARDIONET 6199 CORNERSTONE CT. EAST # 106 San Diego, CA 92121 |
| Contact | Donald Canal |
| Correspondent | Donald Canal CARDIONET 6199 CORNERSTONE CT. EAST # 106 San Diego, CA 92121 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-05-16 |